Clinical trial · Interventional
QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding and drug supply
Summary
Brief summary (as posted)
RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment. PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cognitive function
- timeFrame
- 2 years
Secondary outcomes (6)
- measure
- Tumor response
- timeFrame
- 2 years
- measure
- Time to tumor progression in brain
- timeFrame
- 2 years
- measure
- Survival
- timeFrame
- 2 years
- measure
- Quality of life as measured by FACT subscale
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer meeting the following criteria:
* One to 3 brain metastases, meeting the following criteria:
* No larger than 3 cm
* Greater than 5 mm from the optic apparatus
* Not involving the brainstem, pons, medulla, or midbrain
* Stable systemic disease for the past 3 months
* Less than 3 months since completion of primary treatment
* Measurable CNS disease as defined by RECIST criteria
* No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic evaluation
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 12 weeks
* Karnofsky performance status 60-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 3.0 times ULN
* Serum creatinine ≤ 1.5 mg/dL
* Creatinine clearance \> 50 mL/min
* No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No concurrent major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study participation
* No concurrent active infections
* No known HIV positivity
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior complete resection of all brain metastases
* No prior brain radiation therapy
* No prior temozolomide or erlotinib hydrochloride
* No concurrent enzyme-inducing anti-epileptic drugs
* No concurrent recombinant interleukin-11
* No other concurrent anticancer investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
* No concurrent enrollment on another clinical trial
* Surgery for symptomatic brain lesions prior to radiosurgery allowedReferences
Publications (0)
Data not yet available